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510(k) K213521

Nihon Kohden NKV-330 Ventilator System by Nihon Kohden Orangemed, Inc. — Product Code MNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2022
Date Received
November 3, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Nihon Kohden Orangemed, Inc.

  • K231778 — Nihon Kohden NKV-550 Series Ventilator System (March 1, 2024)
  • K222644 — Nihon Kohden NKV-440 Ventilator System (May 31, 2023)
  • K192307 — Nihon Kohden NKV-550 Series Ventilator System (January 10, 2020)
  • K181695 — Nihon Kohden NKV-550 Series Ventilator System (December 7, 2018)

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  • K170367 — Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large (August 24, 2017)
  • K122715 — STELLAR 150 (June 17, 2013)
  • K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEM (December 14, 2012)
  • K113640 — STELLAR 150 (April 5, 2012)
  • K102985 — V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS (April 5, 2011)